Document Control Specialist II

Bora Pharmaceuticals; Rockville (MD); On-site; USD 44,000 - 55,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Paid time off

Professional development

Job summary

Bora Pharmaceuticals is hiring a QA Document Control Specialist II to manage controlled cGMP documents, templates, and records within a fast-paced biotech environment.

The role emphasizes accurate document control, coordination with multiple departments, and support for internal quality audits, ensuring audit readiness and regulatory compliance across the organization.

Qualifications

• High school diploma or equivalent.
• 2 years' experience in a cGMP manufacturing environment.
• Proficiency with Microsoft Word, Excel and PowerPoint and experience with electronic document management systems.

Responsibilities

• Format, track and issue controlled cGMP documents including protocols, batch records, formbooks and forms.
• Research historical controlled documentation files to provide data on request.
• Create and maintain templates in MasterControl.
• Assist in organizing records, scanning, and archiving.
• Interfaces with departments regarding documentation requirements.
• Support internal quality audits and document management processes.

Skills

Time management

Prioritization

Interpersonal skills

Written and verbal communication

Independent work

Detail orientation

Organizational skills

Education

High school diploma or equivalent

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

About Bora:

Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from FirstinHuman through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purposebuilt for commercialization. Our inspectionproven, bicoastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary:

The QA Document Control Specialist II is responsible for executing key document control-related activities that support various departments at Bora Biologics. This position requires a good understanding of cGMP regulations and document management and computer skills. The individual must possess the ability to handle multiple priorities, be able to interface and communicate effectively with individuals form various departments and be able to work as part of a team.

Essential Functions:

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Responsibilities and Job Duties

• Formats, tracks and issues controlled cGMP documents including protocols, batch records, formbooks and forms.
• Researches historical controlled documentation files to provide data as requested from users.
• Creates and maintains templates in MasterControl.
• Issues and controls logbooks which includes tracking and archiving completed logbooks.
• Assists in the coordination of document management system.
• Interfaces with other departments regarding documentation requirements.
• Participates and supports quality audits (internal).
• Assists in organizing records, scanning, and archiving.
• Performs extensive formatting and editing of word processing documents.
• Maintains document storage and files in an audit ready state.
• Archives, ships, and receives records. Coordinates the pickup, storage, and delivery of records.
• Monitors the movement of records through all tasks from initial receipt through final destruction or archiving.
• Prioritizes various tasks, interprets specific instructions, and applies creative problem-solving techniques in a variety of situations.
• Receives general guidance on routine work and detailed instructions on non-routine work. Interacts with supervisor daily but operates with independence.
• Performs frequent physical exertion including: sitting, repetitive use of hands, lifting and carrying up to 10 pounds.
• Performs other related duties as assigned.
• The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

Minimum Education, Experience & Skills:

Education & Experience

Education: High school diploma or equivalent

Experience:

2 year's experience in a cGMP manufacturing environment

In-depth knowledge and proficiency with personal computers and applicable software packages (Microsoft Word, Excel and, PowerPoint): experience with electronic document management systems

Knowledge:

Ability to manage time, set priorities, and execute processes within required deadlines.

Ability to handle multiple priorities in a fast-paced environment and flexibility to recognize and adapt to changing priorities.

Excellent interpersonal skills and ability to work well within teams.

Excellent written and verbal communications skills.

Ability to work independently in a fast-paced environment with minimal supervision.

Detail oriented and excellent organizational skills

Skills: Proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).

Abilities: Demonstrate Effective verbal and/or written communication at all levels of organization, work effectively in ambiguous situations, and ability to multi-task.

Salary Range:

$44,000-$55,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees' wellbeing, including:

• Competitive salary and performance-based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do - from how we solve challenges to how we support our people. We lead with a solutions-first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.